Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
Sponsor: NSABP Foundation Inc
A PHASE3 clinical study on Breast Cancer, this trial is completed. The trial is conducted by NSABP Foundation Inc and has accumulated 8 data snapshots since 2001. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)OBJECTIVES: * Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer. * Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients. * Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients. * Evaluate the quality of life of a subset of these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral exemestane daily for 5 years. * Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years. Quality of life is assessed at baseline and then every 6 months for 5.5 years. Patients are followed every 6 months for 6 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and...
OBJECTIVES:
* Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer. * Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients. * Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients. * Evaluate the quality of life of a subset of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral exemestane daily for 5 years. * Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years.
Quality of life is assessed at baseline and then every 6 months for 5.5 years.
Patients are followed every 6 months for 6 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
May 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- NSABP Foundation Inc
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .